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Two Minnesota research centers are part of national study to determine the best treatment for diabetes

Monday, November 3, 2014

Type 2 diabetes is a global epidemic. How to optimally use available drugs remains uncertain. In Minnesota alone, more than 300,000 people are estimated to have diabetes and that number continues to grow by 18,000 every year, according to the Minnesota Department of Health. Also, given that the current estimated total costs due to diabetes in Minnesota exceed $3 billion, it is imperative that we spend our health care dollars effectively.

Fortunately, a number of new and existing medications are available to treat diabetes. However, despite the availability of these medications, doctors have little information to guide them to the best treatment option. The GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness) Study, is looking for volunteers at the University of Minnesota and Park Nicollet International Diabetes Center (IDC) in Minneapolis, and is the first study that hopes to provide this critical information.

The GRADE Study, sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (NIH), is the first clinical research study designed to find out which of four FDA-approved diabetes medications, when combined with metformin (Glucophage®), is most effective in treating type 2 diabetes. Metformin is widely accepted as the first medication that should be used to treat type 2 diabetes; however, most patients eventually require an additional medication to manage the disease. The results of GRADE will help doctors guide the management of individuals with type 2 diabetes in the future.

According to Elizabeth Seaquist, M.D., professor of medicine, University of Minnesota, and principal investigator of the University of Minnesota clinical site, “GRADE is a critically important study that will define how we treat diabetes in the future. We are eager to identify study participants who want to help with this question, and are pleased that we can provide them with free diabetes medications, lab tests, and clinic visits for up to seven years.”

The GRADE Study is currently enrolling 5,000 people with type 2 diabetes at nearly 50 medical centers in the United States including the University of Minnesota and IDC, both located in Minneapolis.

“The GRADE Study is the first comparative effectiveness study which will look directly at four of the major treatments for diabetes, compare them and try to determine which one or ones are the best for treating type 2 diabetes,” said Richard Bergenstal, M.D., executive director at IDC and principal investigator of the IDC site.

People with type 2 diabetes may be eligible to join the GRADE Study if they:

Have had type 2 diabetes for less than 10 years

Are over 30 years old

If American Indian, over 20 years old

Only take metformin (Glucophage®) for their diabetes

Are willing to take a second diabetes medication

Are willing to make four office visits per year for the next 4 to 6 years

There are various reasons why people with diabetes want to participant in the GRADE Study. For many, it’s because they want to give something back, and help the doctors learn how to better treat diabetes. Anne Swanson, who has been a part of the GRADE Study at IDC for one year, said she wanted to contribute to society and help people with diabetes.

Before joining the study, Swanson says managing her diabetes was challenging. “I didn’t take my medications as regularly as I should have, and my diabetes wasn’t controlled,” she said. “Now I see it in a different light. When you’re part of a study, you have to follow the regimen. When the study is done, I know I’ll have a much different attitude about taking my own medications. The staff has also given me a lot of encouragement and useful tips on how to maintain or improve my glucose levels, diet and exercise.”

The University of Minnesota and IDC sites are committed to determining the best way to treat type 2 diabetes and are eager to find newly diagnosed patients who want to participate. Anyone interested in learning more can contact the University of Minnesota site at 612-626-0143 or grade@umn.edu, or the IDC site at 952-993-3500 or IDCresearch@parknicollet.com. For more information about the GRADE Study visit www.GradeStudy.com.